Accepted Manuscript

Cognitive and behavioral therapies in the treatment of insomnia: a meta-analysis

Annemieke van Straten, Ph.D., Tanja van der Zweerde, M.Sc., Annet Kleiboer, Ph.D.,
Pim Cuijpers, Ph.D., Charles M. Morin, Ph.D., Jaap Lancee, Ph.D.

PII: S1087-0792(17)30034-5
DOI: 10.1016/j.smrv.2017.02.001
Reference: YSMRV 1017

To appear in: Sleep Medicine Reviews

Received Date: 30 August 2016

Revised Date: 11 January 2017
Accepted Date: 1 February 2017

Please cite this article as: van Straten A, van der Zweerde T, Kleiboer A, Cuijpers P, Morin CM, Lancee
J, Cognitive and behavioral therapies in the treatment of insomnia: a meta-analysis, Sleep Medicine
Reviews (2017), doi: 10.1016/j.smrv.2017.02.001.

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 ACCEPTED MANUSCRIPT

Cognitive and behavioral therapies in the treatment of insomnia:

a meta-analysis

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Authors:
Annemieke van Straten, Ph.D.1

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Tanja van der Zweerde, M.Sc.1
Annet Kleiboer, Ph.D.1
Pim Cuijpers, Ph.D.1

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Charles M. Morin, Ph.D.2
Jaap Lancee, Ph.D.3

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Affiliations
1
Department of Clinical Psychology & EMGO Institute for Health and Care Research, VU University
Amsterdam, The Netherlands
2
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Université Laval, École de Psychologie, Québec City, QC, Canada
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Department of Clinical Psychology, University of Amsterdam, The Netherlands
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Corresponding author
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Prof. dr. A. van Straten

Department of Clinical Psychology
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Faculty of Psychology and Education

VU University
Van der Boechorststraat 1
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1081 BT Amsterdam
The Netherlands
Phone: + 31205988970
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Mobile: +31627230697
e-mail: a.van.straten@vu.nl
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Acknowledgements
Prof. Van Straten, Ms van der Zweerde, dr. Kleiboer, prof. Cuijpers and dr. Lancee, declare that they
have no competing interests. Prof. Morin has served as a consultant for Merck, Valeant, and Novartis
and received research support from Novartis. We did not receive any financial support to write this
meta-analysis.

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Summary

Insomnia is a major public health problem considering its high prevalence, impact on daily life, co-

morbidity with other disorders and societal costs. Cognitive behavioral treatment for insomnia (CBTI) is

currently considered to be the preferred treatment. However, no meta-analysis exists of all studies using

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at least one component of CBTI for insomnia, which also uses modern techniques to pool data and to

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analyze subgroups of patients. We included 87 randomized controlled trials, comparing 118 treatments

(3724 patients) to non-treated controls (2579 patients). Overall, the interventions had significant effects

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on: insomnia severity index (ISI; g=0.98), sleep efficiency (SE; g=0.71), Pittsburgh sleep quality index

(PSQI; g=0.65), wake after sleep onset (WASO; g=0.63) and sleep onset latency (SOL; g=0.57), number of

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awakenings (NWAK; g = 0.29) and sleep quality (SQ; g = 0.40). The smallest effect was on total sleep
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time (TST; g=0.16). Face-to-face treatments of at least 4 sessions seem to be more effective than self-

help interventions or face-to-face interventions with fewer sessions. Otherwise the results seem to be
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quite robust (similar for patients with or without comorbid disease, younger or older patients, using or
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not using sleep medication). We conclude that CBTI, either its components or the full package, is

effective in the treatment of insomnia.

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Keywords

Behavior therapy; cognitive therapy; cognitive behavior therapy; insomnia; sleep initiation or
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maintenance disorder
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List of abbreviations

AASM = American Academy of Sleep Medicine

AT = autogenic training
BT = behavioral therapy
CBTI = cognitive behavioral therapy for insomnia
CD = cognitive distraction

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CMI = comorbid insomnia
CT = cognitive therapy
DSM = Diagnostic and statistical manual of mental disorders

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DSISD = Duke structured interview for sleep disorders
ICSD: International classification of sleep disorders
ISI: insomnia severity index
F2F = face-to-face

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NWAK = number of awakenings
NR = not reported
PE = psycho-education

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PI = primary insomnia
PR = progressive relaxation
PSQI: Pittsburgh sleep quality index
RDC = research diagnostic criteria
RCTs = randomized controlled trials
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SC = stimulus control
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SD = standard deviation
SE = sleep efficiency
SH = sleep hygiene
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SIS-D = Structured interview for sleep disorders for DSM-III-R

SOL = sleep onset latency
SR = sleep restriction
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TST = total sleep time

WASO = wake after sleep onset
WLC = wait-list control
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Introduction

Insomnia is a major public health problem. The prevalence of insomnia, which may be characterized by

difficulty initiating or maintaining sleep, with significant distress and impairments of daytime

functioning, is high: about a third of the population suffers from insomnia symptoms, and about 10%

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5 fulfills the criteria for a sleep disorder [1, 2]. Insomnia has a high burden of disease, which impacts daily

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life in different domains [3, 4] and often persists for many years [5]. The societal costs are substantial:

poor sleepers cost society about ten times as much as good sleepers [6]. These societal costs are due to

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increased health care consumption but especially caused by reduced work productivity and increased

work absenteeism [6, 7].

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10 In addition, insomnia is strongly associated with other somatic and mental health problems as
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well as with an increased mortality rate [8-10]. Most notable is the association with cardiovascular

diseases [11-13] and with depression [14-16]. The nature of these associations is still not clear but it has
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been suggested that hyperarousal and the chronic activation of stress responses is a possible pathway
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between insomnia, depression and cardiac disease [13]. There are also indications that insomnia is a
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15 mediator in the increased mortality rates after depression [17].

Treatment of insomnia is highly desirable, mostly to decrease the burden of insomnia itself. But
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it might also contribute to a decrease of the associated somatic and mental health problems such as

depression and cardiovascular risk.

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Several meta-analyses have shown that benzodiazepine-receptor agonists are effective in

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20 enhancing sleep in the short run, but with risks of negative side effects and limited evidence for their

long-term efficacy [18-20]. Various non-pharmacological treatments have been developed as

alternatives. These non-pharmacological treatments can be classified as educational (psycho-education,

sleep hygiene), behavioral (relaxation, sleep restriction, stimulus control, paradoxical intention) or

cognitive (identifying and challenging dysfunctional thoughts and excessive worries about sleep; [21-

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26]). Since the 1990s it has become popular to offer these non-pharmacological treatments in (various)

combinations. These combinations are usually referred to as cognitive behavioral therapy for insomnia

(CBTI).

Several excellent (systematic) reviews and meta-analyses have been written on CBTI; they

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5 conclude that CBTI is effective [27-33] in primary [34] and comorbid [35, 36] insomnia and CBTI is at

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least as effective as pharmacotherapy [37, 38]. As a result, the American College of Physicians recently

recommended CBTI as the initial treatment for all adults with insomnia [39]. Even though some of these

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reviews pooled the data of individual studies [e.g. 28, 29, 35], to our knowledge, no recent meta-analysis

exists that includes all CBTI studies and that uses modern techniques to pool data and to analyze the

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10 subgroups of patients which might benefit most from CBTI.
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The aim of this meta-analysis is to quantify the effects of educational, behavioral and cognitive

therapies for insomnia, based on all available randomized controlled trials, and to perform subgroup
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analysis as a function of several potential moderators (e.g. comorbidity, sleep medication, year of
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publication) of treatment outcomes.

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Method
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Search strategy

We carried out a comprehensive literature search in PubMed, PsycINFO, EMBASE and the Cochrane
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central register of controlled trials. We combined terms indicative of insomnia (e.g. insomnia, sleep
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20 disorders, sleep initiation and maintenance disorders) with those of psychological treatment (e.g.

psychotherapy, cognitive therapy, behavior therapy). For example for PsycINFO we used (DE=("sleep

disorders" or "insomnia")) and(DE=("psychotherapy" or "behavior therapy" or "cognitive behavior

therapy" or "cognitive therapy")). We searched all literature up to December 2015. Titles and abstracts

were screened by one person (AvS, TvdZ, AK or JL). Only those records that were definitely not suitable

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(e.g. not a randomized trial, a biological or medical treatment) were excluded in this phase. We

retrieved the full papers of the remaining 196 references. Those papers were examined independently

by two of the four researchers (AvS, TvdZ, AK or JL). In case of disagreement the paper was discussed

with the third and fourth reviewer until consensus was achieved.

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5

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Inclusion criteria

We used the following inclusion criteria: 1) the study had to be a randomized controlled trial (RCT), 2)

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investigating CBTI or at least one component of it, 3) for adults of 18 years or older, 4) with insomnia, 5)

in comparison with a non-active control group (e.g. waitlist control, care-as-usual, or a minimal

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10 intervention such as psycho-education about sleep or sleep hygiene information), 6) reporting on sleep
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diary outcomes. We identified the following treatments as being part of CBTI: psycho-education, sleep

hygiene, relaxation, sleep restriction, stimulus control, paradoxical intention, and identifying and
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challenging dysfunctional thoughts (about sleep). We excluded all other therapies such as interpersonal
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therapy, bright light therapy, exercise and biofeedback. Cognitive distraction was also excluded because

15 it only encompassed advice on topics to think about (e.g. a recipe or a plot of a television show) or
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things to do (e.g. to read a book or watch television). We also excluded studies: aimed at children or
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adolescents, at tapering of medication, which used outcomes such as fatigue instead of sleep, or which

were aimed at treating another mental health disorder and reported insomnia as a secondary outcome.
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We also excluded studies with insufficient information to calculate the effect size (e.g. those presenting
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20 scores in a plot without providing means, standard deviations or other relevant statistics).

Data extraction

We coded the following characteristics of the studies: 1) year of publication, 2) setting where patients

were recruited (community, primary care, other care facilities, university), 3) the definition of insomnia

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that was used, 4) co-morbidity (e.g. insomnia in chronic pain patients), 5) age group (young adults, older

adults or all adults), 6) the treatment format (individual, group or self-help), 7) the number of treatment

sessions, 8) the use of sleep medication (allowed, not allowed or not reported), 9) the type of control

group (e.g. waitlist, no treatment), 10) the number of patients included in the treatment and control

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5 group, and 11) type of intervention. We distinguished four categories of interventions: a) full CBTI which

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had to include an educational component as well as a behavioral and cognitive one, b) behavioral

therapy which had to include both stimulus control and sleep restriction (with or without an educational

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component), c) relaxation, and d) “other” which included e.g. stimulus control only or paradoxical

intention only. Two independent assessors coded each study and differences were discussed by the

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10 review team until consensus was reached (AvS, TvdZ, AK, or JL).
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Quality assessment
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We assessed the validity of the studies using the criteria suggested by the Cochrane Handbook [40]: 1)
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adequate sequence generation, 2) concealment of allocation, 3) adequate handling of incomplete

15 outcome data, and 4) selective reporting of data. We did not assess the blinding of patients or therapists
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since this is impossible in psychotherapy research nor did we assess blinding of outcome assessors since
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all reported outcomes are based on self-report. Two reviewers conducted the quality assessment

independently of each other (AvS, TvdZ, AK, or JL).

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20 Meta-analyses

We examined the effects as observed immediately after treatment (post-test). We calculated between

group effect sizes for all individual studies using Hedges’ g. This is the standardized mean differences (or

Cohen’s d) after adjusting for small sample sizes [41, 42]. The effect size represents the difference

between two groups in number of standard deviations. Effect sizes of 0.56-1.2 can be assumed to be

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large, while effect sizes of 0.33-0.55 are moderate, and effect sizes of 0-0.32 are small [43]. To calculate

those effect sizes, we used the available statistics as published in the papers (e.g. means and standard

deviations, mean difference score and 95% confidence interval).

To calculate the individual effect sizes as well as the pooled mean effect size we used the

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5 computer program Comprehensive meta-analysis (CMA) version 3.3.070 for Windows, developed for

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support in meta-analysis (www.metaanalysis.com). We first performed the analyses on all studies and

then checked for outliers. An outlier was defined as a study in which the 95% confidence interval around

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the effect size did not overlap with the 95% confidence interval around the pooled effect size. We then

repeated the analysis without the identified outliers.

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10 As we expected considerable heterogeneity, we calculated pooled effect sizes with the random
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effects model. We tested heterogeneity under the fixed effects model using I2 which describes the

variance between studies as a proportion of the total variance. A value of 0% indicates no observed
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heterogeneity and larger values show increasing heterogeneity. We calculated 95% confidence intervals

(CI) around I2, using the non-central Chi squared-based approach within the heterogi module for Stata.
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15 We tested for publication bias by visually inspecting the funnel plot and by conducting the
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Egger’s test of the intercept. We used the the Duval and Tweedie [44] trim and fill procedure to estimate
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the effect size after the publication bias had been taken into account. It also provides an estimate of the

number of missing studies.

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In addition, we performed univariate subgroup analyses on three different outcome variables:

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20 sleep onset latency (SOL), sleep efficiency (SE) and insomnia severity index (ISI). We chose SOL because

this was the most frequently used outcome variable, SE because this is often described as the preferred

primary outcome in insomnia research and ISI because this questionnaire is gaining popularity rapidly as

an outcome and is much easier to collect than a sleep diary. For these three variables we tested whether

the effect size was significantly related to treatment, patient or study variables. We used the mixed

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effects model, which pools studies within subgroups with the random effects model, but tests for

significant differences between subgroups with the fixed effects model. Lastly, we conducted

multivariate meta regression analysis. We only included variables that were univariate associated with

the outcome with a p-value of 0.25 or less. Two variables were excluded because of collinearity: type of

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5 treatment (which was collinear with yes/no full CBTI treatment) and number of sessions (which was

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collinear with treatment format since self-help interventions cannot be divided into discrete sessions).

We entered all the variables in the model simultaneously and calculated standard regression

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coefficients. Finally, we reported the overall proportion of the total between-study variance which is

explained by the model (R square).

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Results
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Selection of studies
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Figure 1
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The titles and abstracts of 1727 references were screened (after removal of 290 duplicates). We
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15 excluded 1503 references and retrieved full-text papers of the remaining 224 references. A total of 137

papers did not fulfill our inclusion criteria (Figure 1). We included 87 papers on RCTs in which (a
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component of) CBTI was examined in comparison to a non-treatment control group [45-131]. Some

studies had more than two arms and examined different active interventions in comparison to a control.
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Of the 87 studies, 63 examined one intervention, 18 examined two interventions, 5 studied three
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20 interventions and 1 studied four interventions. The total number of comparisons was therefore 118.

There were 6.303 patients included in the studies, 3.724 in the intervention groups and 2.579 in the

control groups.

Characteristics of included studies

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Table 1

The first studies were published in 1974 but the majority of studies (n=62; 71%) were published in or

after the year 2000 (Table 1). Most studies recruited people from the general population (n=59; 68%). A

minority of the studies recruited people through care facilities (primary care or specific care settings,

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5 n=20; 23%) and many of those studies additionally recruited via general media. The remaining 8 studies

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(9%) recruited participants through universities. Some studies excluded older patients (n=18; 21%),

while others specifically focused on the elderly (n=20; 23%). The remaining studies either included both

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younger and older adults (n=30; 34%) or did not specify which age categories were eligible for the study

(n=19; 22%). Some studies specifically examined insomnia in the context of another somatic disorder

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10 (n=15; 17%) or a mental disorder (n=5; 6%) but most studies aimed to examine primary insomnia and
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therefore excluded patients with mental or somatic illnesses (n=45; 52%). For the remaining studies

comorbidities were allowed but it was not always clear whether or not they excluded patients with
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severe illnesses (n=22; 25%). About half of the studies allowed the use of sleep medication during the
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study (n=40; 46%), while in the other half of the studies sleep medication was either not allowed (n=37;

15 43%) or it was not reported how the use of sleep medication was handled (n=10; 11%).
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Out of the 118 interventions included in this meta-analysis 51 (43%) consisted of full CBTI
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(educational component as well as a behavioral and cognitive one), 13 (11%) of behavioral therapy

(stimulus control and sleep restriction but no cognitive element), 23 (19%) of relaxation (without any
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other treatment element) while the remaining 31 interventions (26%) consisted of “other” treatments
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20 such as paradoxical intention only, or stimulus control only. About a third of the treatments (n=35; 30%)

was offered in group format, about half (n=57; 48%) was offered as individual face-to-face therapy while

the remaining studies examined self-help treatments (either through books, audio or the Internet, n=26;

22%). The individual or group treatments typically took up to 6 sessions (n=71; 60%). Of the 87 studies,

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41 used a waitlist control (47%), 14 no treatment (16%), 20 placebo (mostly quasi-desensitization; 23%)

and 12 offered psycho-education (14%).

Quality assessments

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5 Out of all 87 studies 38 (44%) reported an adequate sequence generation for their randomization while

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the remaining 49 studies did not report how they handled this. Only 23 studies (26%) reported that their

random allocation had been concealed. For the other 64 studies (74%) this remained unclear. About half

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of the studies (n=45; 52%) handled their missing data well by performing intention-to-treat analyses. For

another 24 studies (27%) it was clear that missing cases had been dropped from their analysis. For the

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10 other 18 studies (21%) it remained unclear how many patients were randomized, how many patients
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had dropped out and how missing data was handled.

We used self-report sleep diary data to extract our outcome data. Many different variables
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might be extracted from a sleep diary and this was reflected in the included studies. Of all the 118
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comparisons 108 calculated SOL. This is the time it takes to fall asleep after going to bed and turning the

15 lights out/attempting to sleep. The SE, the percentage of time having slept while being in bed, was
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calculated for 79 comparisons, total sleep time (TST) for 91, the time being awake after sleep onset
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(WASO) for 71, sleep quality (SQ) for 40 and the number of awakenings during the night (NWAK) for 36

comparisons. Out of all 87 studies 38 also included the insomnia severity index (ISI [132]) as an outcome
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measure and 19 included the Pittsburg sleep quality index (PSQI [133]).
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Overall effects

Table 2

The CBTI interventions had positive statistically significant effects on all reported sleep outcomes (Table

2). The ISI showed the largest effect (g=0.98) but large effects were also obtained for SE (g=0.71), PSQI

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(g=0.65), WASO (g=0.63) and SOL (g=0.57). Small to moderate effect sizes were observed for NWAK (g =

0.29) and SQ (g = 0.40). The smallest effect was on TST (g=0.16). Since there were studies with

extremely high effect sizes as well as studies with extremely low effect sizes, deleting the outliers did

not influence the effect sizes substantially. It did reduce the percentage of heterogeneity (I2).

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5 Heterogeneity remained quite high for the ISI and the SQ but was small to moderate for all outcomes

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based on sleep diaries. Of the 87 studies, 24 (28%) examined more than one treatment while using only

one control group for each study. This means that the comparisons from these studies were not

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independent of each other which may have resulted in an artificial reduction of heterogeneity. We

examined the possible effects by conducting sensitivity analyses in which we included only one

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10 comparison per study. First, we included only the comparison with the largest effect size from that study
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and then we conducted another analysis in which we included only the smallest effect size. The resulting

effect sizes and heterogeneity statistics were highly comparable with the ones found in the overall
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analyses (Table 2) and therefore not shown.
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Association between effect and treatment, patient and study variables

15 Table 3
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We studied the association between the effect size on SOL, SE and ISI on the one hand and different
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treatment, patient and study variables on the other (Table 3). Overall the results were mixed and

depended on the outcome variable.

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First, we describe the results for SOL. SOL was significant (p < 0.05) related to type of treatment,
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20 age, and year of publication: effect sizes were higher for relaxation and “other” treatments than for CBTI

or behavioral treatments and higher for young adults than for older adults. There seems to be a U-shape

association between SOL and the year of publication: the oldest studies have the highest effect sizes,

but after the 90s the effect sizes start to increase again. There were also significant associations for the

use of sleep medication and concealment of allocation. In these cases effect sizes were higher for

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studies that did not report the use of sleep medication and for studies that did not report allocation

concealment. There were borderline significant (p < 0.10) associations for SOL with treatment format

(individual and group treatments yielded higher effect sizes than self-help), number of sessions (longer

treatments yielded better effect sizes than shorter treatments), recruitment population (non-

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5 community samples yielded higher effect sizes), and type of control (no treatment had highest effect

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size). Overall, heterogeneity seemed to be moderate.

Second, we describe the results for SE. Some of the results for SE were comparable to those of

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SOL. This means that there was a (borderline) significant association with: type of treatment (higher

effect sizes for “other” treatment than for CBTI or behavioral treatments), treatment format (higher

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10 effect sizes for individual and group therapy than for self-help), number of sessions (higher effect sizes
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for 5 or more sessions than for 1 to 4), age (higher effects for younger people than for older people),

recruitment population (higher effect sizes for patients recruited in other ways than general media /
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community) and year of publication (the most recent publications yielded the highest effect sizes). There
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were also some differences between the results for SOL and SE because SE was also (borderline)

15 significantly associated with comorbidity (people with comorbid disorders obtained higher effects) and
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ITT analysis (studies using ITT analysis showed higher effects than studies which did not report this).
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Third, we describe the results for ISI. ISI was significantly related only to the type of control:

studies with waitlist controls showed higher effects than studies with other type of control groups.
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There was furthermore a borderline significant association with allocation concealment: studies not
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20 reporting this yielded higher effect sizes.

Table 4

We examined a number of variables which might be related to each other (e.g. studies

examining self-help might have included younger people than studies examining individual therapy).

Therefore, we also performed a multivariate analysis. The multivariate model showed significant

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relations with SE and ISI for treatment format. Self-help interventions performed worse than individual

face-to-face interventions. Two other significant associations were related to study quality: studies that

did not report allocation concealment had higher effects on SOL and ISI, and studies that did not report

age had higher effects on SE and ISI. Finally, two significant associations were related to study design:

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5 studies with a waitlist control showed higher effect sizes on ISI than studies with an information control

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(or other minimal interventions) and more recent studies showed higher effect sizes on SE than older

studies.

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Publication bias

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10 Visual inspection of the funnel plot seemed to indicate that there was publication bias and this was
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confirmed by Egger’s test (p < 0.01 for SOL, SE and ISI). This means that there are studies which are not

published because of their small effects. Duval and Tweedie have developed a method (implemented in
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CMA) which is able to estimate how many studies are missing and what their effect size would have
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been. It re-calculates the pooled effect size while imputing the missing effect sizes. The results showed

15 that 27 studies were missing for SOL, 21 for SE, and 13 for ISI. The effects remained statistically
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significant after re-calculation but became smaller (g=0.41 for SOL, g = 0.49 for SE, and g = 0.71 for ISI;
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Table 3).
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Discussion
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20 In this meta-analysis on 87 studies with 118 comparisons we examined the effects of educational,

behavioral and / or cognitive treatments for insomnia. The overall effects were large on insomnia

severity (ISI; g = 0.98), sleep efficiency (SE; g=0.71), the Pittsburgh sleep quality Index (PSQI; g=0.65),

wake after sleep onset (WASO; g=0.63) and sleep onset latency (SOL; g=0.57). Small to moderate effect

sizes were observed for number of awakenings (NWAK; g = 0.28) and sleep quality (SQ; g = 0.40). The

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smallest effect was on total sleep time (TST; g=0.16). Heterogeneity was highest for self-reported

outcomes (ISI and SQ) and more moderate for sleep diary variables. Multivariate analysis showed

different associations for different sleep variables (SOL, SE and ISI). We found that face-to-face

interventions perform better than self-help interventions (on SE and ISI but not on SOL), newer studies

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5 and studies with a waitlist control yielded higher effect sizes (on SE and ISI respectively), and studies

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that did not report age or allocation concealment reported higher effect sizes (SOL and ISI, and SE and

ISI respectively).

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The overall effects for insomnia treatments seem to be in line with psychological treatments for

other disorders such as depression (d = 0.78 [134]), social phobia (d=0.70 [135]), panic disorder with

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10 (d=0.78) or without agoraphobia (d=1.04 [136]). However, the magnitude of the effects varied between
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the different outcome parameters. Quite large effect sizes were obtained for scores on the

questionnaires of insomnia severity (ISI) and sleep quality (PSQI) even though there was considerable
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heterogeneity. The ISI and PSQI do not rate the nocturnal symptoms of insomnia alone but also their
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daytime consequences. However, it would be premature to conclude from this that insomnia

15 treatments are effective in improving daytime functioning. We need studies examining day-time
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functioning in more detail (e.g. examining fatigue, work productivity, social activities) before we can
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make such a statement.

Several indices derived from the daily sleep diary (SE, WASO and SOL) also yielded high effect
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sizes, indicating that treatment was very effective for improving sleep continuity. As previously reported
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20 in other studies, the actual number of hours of sleep (TST) improved only modestly. Post-hoc analysis

did not seem to indicate that TST was related to type of treatment indicating that TST was not

(artificially) reduced because of sleep restriction. Thus, the findings indicate that treatment is mostly

effective for improving sleep continuity/efficiency and sleep quality, with some evidence of improved

daytime functioning as well. It must be noted, however, that not all outcomes were reported in all

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studies. This hampers the interpretation of the differences in effect sizes on the various measures. Our

knowledge about insomnia and its treatments would be greatly enhanced if future randomized clinical

trials would use the same outcome measures to estimate treatment effects [137].

Overall, CBTI treatments for insomnia are effective but the next question is: can we explain the

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5 differences in effects between studies (the heterogeneity)? First we examined this by comparing the

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studies that used full CBTI to those who did not include all CBTI components. There were no statistically

significant differences between the effects of those studies. Second we compared full CBTI to different

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(combinations of) components. Univariate analyses showed that relaxation works well for SOL and that

“other” treatments work the best on all sleep outcomes. The high effects for “other” treatments

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10 compared with full CBTI are counterintuitive. One explanation might be that these studies tend to be
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older and these older studies tend to have poorer quality (no report on randomization sequence or

randomization concealment). The effect sizes for the full CBTI package seem to be similar to those for
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behavioral techniques only. This brings into question the additional effect of the cognitive modules. One
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recent study was aimed at this question and compared behavioral treatment (BT) with cognitive

15 treatment (CT) and full CBTI [138]. Even though this study did not demonstrate significant differences
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among the three treatments on the post-test continuous ISI scores, there were some indications that BT
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worked faster than CT but that the effects of CT lasted longer than those of BT. Therefore, to make use

of both effects, the authors recommended full CBTI. Our current meta-analysis, which did not include
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long-term follow-ups, can neither endorse nor reject this recommendation.

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20 Another reason for the failure to detect clear and consistent differences in effects between the

different treatments is that there is considerable variety in the treatments within one category (e.g. full

CBTI). This has been described previously with respect to sleep restriction treatment [139]: there was a

great variability in the way the average number of hours asleep was calculated, the minimum number of

hours in bed, how bed and rise times were positioned, what the sleep efficiency criterion was for

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extending the sleep window, for how many days this criterion should be reached before actually

extending etc. In all likelihood, these variations also exist for the other CBTI elements. Our data support

this idea since we demonstrated quite large 95% confidence intervals for heterogeneity within the

different treatment subgroups. Ultimately we need to standardize our treatment components and

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5 examine differences in effect by direct comparisons. We recommend that more dismantling studies be

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performed.

The treatment format was significantly related to all studied sleep outcomes. More specifically:

SC
self-help interventions seem to perform worse than face-to-face interventions, especially on SE and ISI.

This is in contrast to studies on other mental disorders which often yield a similar or quite similar effect

U
10 size for self-help interventions compared with face-to-face interventions [140, 141]. Moreover, some of
AN
the recent studies on self-help interventions demonstrated very high effect sizes, even those without

any human support [64, 98]. Since insomnia is so prevalent and self-help interventions are much easier
M
to offer than face-to-face treatments against lower costs because of reduced therapeutic input, we
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conclude that self-help interventions are worthwhile as a first step of treatment. But sufficient face-to-

15 face options need to be available for those who do not recover. Furthermore, we urgently need studies
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comparing the two treatment formats directly since two recent studies showed mixed results with one
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not finding differences in effect [142] and the other finding face-to-face treatment superior to online

treatment [87].
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It remains unclear to what extent the number of treatment sessions is important to obtain
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20 optimal effects. There are some indications from the univariate analysis that 1 to 4 session treatments

yield lower effect sizes than treatments which are composed of more than 4 sessions. However, these

results are not very robust and do not apply to the ISI. It was not possible to test the effect of the

number of session in a multivariate analysis since the self-help interventions all had 0 sessions and this

caused collinearity. The only study that directly compared the treatment duration (1, 2 ,4 and 8 sessions;

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[61]) concluded that a duration of 4 sessions was optimal. Since Edinger and colleagues [61] concluded

that 4 sessions were optimal, and we have indications that 5 or more sessions are more effective, we

conclude that 1 to 3 session treatments seem to be less effective than longer treatments. However,

more studies directly comparing treatment length (and costs) are needed to establish optimal treatment

PT
5 length.

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Interestingly, there seems to be an association between publication year and treatment effect.

For SE the newest studies (after 2010) showed significantly higher effect sizes than those published

SC
between 1990 and 2010. There were no studies measuring SE before 1990. For SOL, there seemed to be

a U-shaped association: the oldest studies showed the highest effects. Effect sizes then decreased over

U
10 time but the newest studies yielded higher effects again. The association disappeared in the multivariate
AN
analysis but this might be because in this analysis we used the actual publication year instead of

categories. Furthermore, we tested for a linear relationship and not for a U-curved relationship. A
M
possible explanation for the U-curve in SOL is the variation in study design over time. The older studies
D

(performed in the 1970s) more often used homogeneous samples (young, without comorbidity, without

15 sleep medications). They were also smaller (less patients) and less methodologically rigorous and
TE

therefore more susceptible to different types of bias. These methodological shortcomings might have
EP

led to higher effects. This is also in line with some of the other results of the multivariate analysis: in

studies of poorer methodological quality the interventions seemed to perform better. Studies that did
C

not report age or did not report the way they concealed treatment allocation showed better results than
AC

20 those who did. However, it might still be possible that the treatments offered in the 1970s were truly

more effective than those offered later on. The majority of these studies focused on either relaxation or

paradoxical intention. Maybe these treatments are indeed effective but have been pushed aside by the

current fashion of CBTI? After all, this also occurred in depression treatment where it has become state-

of-the-art to offer CBTI even though there is no conclusive proof that CBTI actually works better than

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other treatments [134]. More research is needed in which older insomnia treatments are directly

compared with newer ones.

The treatment effects were not significantly related to the presence of comorbidity, the

allowance to use sleep medication, or to age. This is in line with previous reviews of insomnia

PT
5 treatments which argued that CBTI is effective for younger and older adults, for patients with and

RI
without comorbidities, for medication-free patients as well as for chronic hypnotic users [32].

An important limitation of this meta-analysis is that we only could include studies of which the

SC
results were published. There were indeed indications of publication bias. This suggests that the actual

effects of CBTI on insomnia might be smaller although still significant. Another limitation is that not all of

U
10 the studies used the same outcome measure. Differences in effects between outcomes might therefore
AN
reflect differences between studies rather than real differences in effect. Finally, many quality criteria

were not met by the studies which might mean that we overestimate the true effectiveness.
M
Despite the limitations we conclude that CBTI, either its components or the full package, is
D

effective in the treatment of insomnia. Face-to-face treatments and treatments of at least 4 sessions

15 seem to be more effective than self-help interventions or face-to-face interventions with fewer sessions.
TE

Otherwise the results seem to be quite robust (similar for patients with or without comorbid disease,
EP

younger or older patients, using or not using sleep medication). We need more high quality research,

comparing different treatment components directly with one another, to understand whether or not full
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CBTI is more effective than its separate components and whether or not there are other (older)
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20 treatments that are actually as effective as CBTI.

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Practice points
- Cognitive behavioral treatment for insomnia is effective with large overall effects on insomnia
severity, sleep efficiency, wake after sleep onset, and sleep onset latency. The magnitude of
these effects is in line with psychological treatments for other disorders.
- The smallest effects of cognitive behavioral treatment for insomnia are found for total sleep
time.
- Face-to-face treatments and treatments of at least 4 sessions seem to be more effective than

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self-help interventions or face-to-face interventions with fewer sessions.

RI
Research agenda
Future studies on cognitive behavioral treatment for insomnia should focus on:
- Determining which treatment components are essential for delivering cognitive behavioral

SC
treatment for insomnia
- Comparing face-to-face treatments for insomnia with their online counterpart
- Evaluating the optimal treatment length for cognitive behavioral treatment for insomnia

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- Directly comparing earlier insomnia interventions (e.g. relaxation) to newer ones (e.g. CBTI)

AN
M
D
TE
C EP
AC

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Table 1. Characteristics of the included studies on (elements of) CBT for insomnia

Recruit Co- F2F N Contr N

study ment Definition insomnia morbidity Age interv format sess EXP group CTR

PT
45
Alperson 1979 Comm SOL ≥ 30m Allowed 17-54 Relax+SC Group 2 7 WL 7

RI
46
Arnedt 2011 Care SOL ≥ 30m, ≥ 3 n/w, ≥ 1mo + ISI ≥ 8 Alcohol 18-65 CBTI Indiv 4 9 Plac 8

47

SC
Arnedt 2013 Care wake time > 60m+ SE < 85% Excluded 18-65 CBTI Phone 4-8 18 Info 15

48
Ascher 1979 Comm SOL ≥ 60m, ≥ 3 n/w Excluded 18+ Pdox Indiv 4 8 No tx 9

U
49
Ascher 1980 Comm No criteria Excluded 18+ Pdox A Indiv 4 10 WL 10

AN
Pdox B Indiv 4 10

50
Borkovec 1976 Univ Average SOL ≥ 30 mins Allowed - Relax Group 4 12 No txt 12

M
51
Bothelius 2013 Care Poor sleep > 1m month + daytime imp Excluded 18+ CBTI Group 5 32 WL 34

D
52
Broomfield 2003 Univ SOL ≥ 30m, > 3 n/w + PSQI > 5 Excluded 16-65 Pdox SH n/a 17 No tx 17

Buysse 2011
53
Care
TE
DSM-IV and ICSD-2 insomnia diagnosis Allowed elderly Behav Indiv 2 42 Info 40

54
EP
Carr-Kaffashan 1979 Comm Average SOL ≥ 30 m, ≥ 6 mo Allowed 18+ Relax Indiv 4 16 Plac 14

55
Creti 2005 Comm No criteria Excluded 55+ Relax SH n/a 14 No tx 13
C

56
Currie 2000 Care DSM-III insomnia diagnosis with SIS-D and ICSD diagnosis Pain < 60 CBTI Group 7 32 WL 28
AC

57
Currie 2004 Care SOL ≥ 30 m, ≥ 3 n/w Alcohol 18+ CBTI Indiv 5 20 WL 20

CBTI SH n/a 20

58
Edinger 2001 Comm mean WASO ≥ 60 m, ≥ 6 mo Excluded 40-80 behavioral Indiv 6 25 Plac 25

Relax Indiv 6 25

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 ACCEPTED MANUSCRIPT

Recruit Co- F2F N Contr N

study ment Definition insomnia morbidity Age interv format sess EXP group CTR

59
Edinger 2005 Comm mean WASO ≥ 60 m Fibromyalgia 21-65 Behavioral Indiv 6 18 No tx 11

PT
60
Edinger 2003 Primary Difficulty initiating or maintaining sleep ≥ 1 mo + daytime imp Excluded - BT Indiv 2 10 plac 10

RI
care

Edinger 2007 61 Comm mean WASO ≥ 60 m, ≥ 6 mo Excluded 40-75 behavioral Indiv 1 16 WL 11

SC
behavioral Indiv 2 18

behavioral Indiv 4 24

U
behavioral Indiv 8 17

AN
62
Edinger 2009 Care mean SOL + WASO ≥ 60 m Excl (PI) - behavioral Indiv 4 20 Info 40

Allow (CMI) behavioral Indiv 4 21

M
63
Ellis, 2015 Comm Difficulty initating or maintaining sleep or early morning awakening, excluded - CBTI Indiv 1 20 WL 20

≥ 3 n/w, < 3 mo

D
64
Epstein 2007 Comm SOL or WASO ≥ 30 m, ≥ 3 n/w, ≥ 2 weeks + daytime imp
TE Cancer 18+ behavioral Group 4 40 Info 41

65
Epstein 2012 Comm SOL or WASO ≥ 45 m, ≥ 3 n/w, ≥ 6 mo+ day-time imp Excluded 55+ PE+SR Group 4 44 WL 50
EP
PE+SC Group 4 44

PE+SC+SR Group 4 41
C

66
Espie 1989 Care Mean SOL ≥ 30 m, ≥ 1 year Excluded - SC Group 8 14 No tx 13
AC

Relax Group 8 14

Pdox Group 8 15

67
Espie 2001 Care ICSD difficulty falling/maintaining sleep, ≥ 4 n/w, ≥ 3 mo + PSQI ≥ 5 Excluded - CBTI Group 6 74 WL 65

68
Espie 2007 Care ICSD / DSM-IV criteria of insomnia Allowed - CBTI Group 5 107 No tx 94

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 ACCEPTED MANUSCRIPT

Recruit Co- F2F N Contr N

study ment Definition insomnia morbidity Age interv format sess EXP group CTR

69
Espie 2008 Care SOL or WASO ≥ 30 m, ≥ 3 n/w, ≥ 3 mo + PSQI ≥ 5 Cancer 18+ CBTI Group 5 100 No tx 50

PT
70
Espie 2012 Comm poor sleep ≥ 3 n/w, ≥ 3 mo + daytime imp + SE < 80% Excluded 18+ CBTI SH n/a 55 WL 54

RI
71
Freedman 1976 Univ SOL ≥ 60 m, ≥ 4 n/w, ≥ 6 mo Excluded - Relax Indiv 6 6 Info 6

72

SC
Friedman 2000 Comm SE < 80%, SOL > 30m, TST < 6hr, WASO > 30 m, ≥ 5 n/2w Excluded 55+ SC+SR Indiv 5 16 Info 11

73
Harris 2012 Comm SOL > 30m, ≥ 3 n/w, ≥ 6 mo + daytime imp Excluded 18-65 SC Indiv 5 20 Info 20

U
74
Haynes 1974 Univ NR - 18-21 Relax Group 6 7 plac 7

AN
75
Ho 2014 Comm SOL or WASO ≥ 3 n/w, ≥ 3 mo + daytime imp Allowed 18+ CBTI SH+ n/a 103 WL 105

CBTI SH- n/a 104

M
76
Irwin 2014 Comm SOL or WASO ≥ 3 n/w, ≥ 3 mo + daytime imp Excluded 55+ PE+SC+CT group 16 50 info 25

D
+relax

Jacobs 2004
77
Comm
TE
SOL > 60m, ≥ 3 n/w, ≥ 6 mo + daytime imp Excluded 25-64 CBTI Indiv 4 15 Plac 15

78
Jansson 2012 Care SOL or WASO > 30m, ≥ 3 n/w, ≥ 6 mo + daytime imp Hearing 18-65 CBTI Indiv 7 17 WL 15
EP

79
Jernelov 2012 Comm ISI > 10 + poor sleep ≥ 4 weeks Excluded 18+ CBTI SH N/A 44 WL 44

CBTI SH N/A 45
C
AC

Jungquist 2010 80 Care SOL or WASO > 30m, > 3 n/w, > 6 mo Pain 25+ CBTI Indiv 8 19 Plac 9

81
Kaldo 2015 Comm Difficulty initiating or maintaining sleep + daytime imp + ISI > 10 Excluded 18+ CBTI SH n/a 73 Plac 75

82
Kapella 2011 Comm Difficulty initiating or maintaining sleep, waking up too early or poor COPD 45+ CBTI Indiv 6 9 plac 9

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 ACCEPTED MANUSCRIPT

Recruit Co- F2F N Contr N

study ment Definition insomnia morbidity Age interv format sess EXP group CTR

quality sleep

PT
83
Lacks 1983a Comm SOL ≥ 30m, ≥ 1 n/w, ≥ 6 mo Excluded 17-59 Relax Group 4 19 Plac 16

SC Group 4 15

RI
Pdox Group 4 14

SC
84
Lacks 1983b Comm WASO ≥ 30m, ≥ 1 n/w, ≥ 6 mo Excluded 17-59 SC Group 4 7 Plac 8

85
Lancee 2012 Comm SE < 85% + SLEEP-50 ≥ 19 Allowed 18+ CBTI SH N/A 205 WL 202

U
CBTI SH N/A 216

AN
86
Lancee 2015 Comm SOL or WASO > 30m, ≥ 3 n/w, ≥ 3 mo + daytime imp + ISI > 10 Excluded 18+ CBTI SH n/a 36 WL 27

87

M
Lancee 2016 Comm SOL or WASO ≥ 30m, ≥ 3 n/w, ≥ 3 mo + ISI ≥ 10 Excluded 18+ CBTI SH n/a 30 WL 30

Indiv 6 30

D
88
Lichtstein 1999 Comm SOL or WASO ≥ 30m, ≥ 3 n/w, ≥ 6 mo Excluded - Relax Indiv 3 10 WL 10

Lichtstein 2000
89
Comm
TE
SOL or WASO ≥ 30m, ≥ 3 n/w, ≥ 6 mo + daytime imp Illness 58+ Relax+SC Indiv 4 23 WL 21

90
Lichtstein 2001 Comm SOL or WASO ≥ 30m, ≥ 3 n/w, ≥ 6 mo + daytime imp Excluded 59+ Relax Indiv 6 27 Plac 23
EP

SR Indiv 6 24
C

91
Lick 1977 Comm Average SOL ≥ 50m Excluded - Relax+ Indiv 6 10 No tx 10

Relax- Indiv 6 10
AC

92
Lovato 2014 Comm WASO > 30m, ≥ 3 n/w, > 6 mo + daytime imp Exluded Older CBTI Group 4 86 WL 32

93
Manber 2008 Comm SOL or WASO ≥ 30m, TST ≤ 6.5hrs, ≥ 3 n/w MDD 18-75 CBTI Indiv 7 15 Plac 15

94
McCrae 2007 Comm SOL > 31m, ≥ 3 n/w, ≥ 6 mo + daytime imp Excluded 65+ SC+SR Indiv 2 11 info 11

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 ACCEPTED MANUSCRIPT

Recruit Co- F2F N Contr N

study ment Definition insomnia morbidity Age interv format sess EXP group CTR

95
Means 2000 Univ SOL or WASO ≥ 30m + spoor sleep ≥ 2 mo + daytime imp Excluded - Relax Indiv 3 28 No tx 29

PT
96
Mimeault 1999 Comm SOL or WASO ≥ 30m, ≥ 3 n/w, ≥ 1 mo + daytime imp Excluded 18+ CBTI SH N/A 18 WL 18

RI
CBTI SH N/A 18

97
Morawetz 1989 Comm SOL or WASO > 30m, ≥ 3 n/w, ≥ 6 mo + daytime imp Excluded 18-60 SR+relax SH N/A 16 WL 18

SC
SR+relax Group 5 16

98
Morin 1988 Comm WASO > 30m, ≥ 3 n/w, ≥ 6 mo + daytime imp Excluded 55+ SC Group 6 9 WL 10

U
99
Morin 1993 Comm WASO > 30m, ≥ 3 n/w, ≥ 6 mo + daytime imp Excluded 60+ CBTI Group 8 12 WL 12

AN
100
Morin 1999 Comm SOL or WASO ≥ 30m, ≥ 3 n/w, ≥ 6 mo + daytime imp Excluded 55+ CBTI Group 8 18 Plac 20

M
101
Morin 2005 Comm Poor sleep ≥ 3 n/w Allowed 18+ CBTI SH n/a 96 No tx 96

D
102
Nicassio 1974 Comm Average SOL ≥ 30m Allowed - RelaxA Indiv 4 8 No tx 7

TE RelaxB Indiv 4 8

103
Norell-Clarke 2015 Comm Insomnia symptoms > 3 n/w + ISI > 10 Depression - CBTI Group 4 32 Plac 32
EP
104
Pigeon 2012 Care SOL or WASO > 30 m, ≥ 3 n/w, ≥ 6 mo Pain 35-75 CBTI Indiv 10 6 WL 4

105
Riedel 1995 Comm SOL > 30m, ≥ 3 n/w, ≥ 12 mo Excluded 60+ PE+SR Group 4 25 WL 25
C

106
AC

Riedel 1998 Comm SOL or WASO or early awakening > 30m, ≥ 3 n/w, ≥ 6 mo Excluded 19-80 SC Indiv 2 11 WL 10

107
Riley 2010 Comm SOL or WASO or early awakening > 30m, ≥ 3 n/w, ≥ 6 mo Excluded 18-65 SC+SR SH n/a 57 Info 33

108
Ritterband 2009 Comm Poor sleep ≥ 3 n/w, ≥ 6 mo + daytime imp Allowed 18-65 CBTI SH n/a 22 WL 23

109
Ritterband 2012 Comm Poor sleep ≥ 3 n/w, ≥ 6 mo + daytime imp + average TST ≤ 6.5 hr Cancer 21+ CBTI SH n/a 14 WL 14

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 ACCEPTED MANUSCRIPT

Recruit Co- F2F N Contr N

study ment Definition insomnia morbidity Age interv format sess EXP group CTR

110
Rybarczyk 2002 Care SOL ≥ 45m or WASO ≥ 60m or TST ≤ 5 hr, ≥ 3 n/w Illnesses 55+ CBTI Group 8 16 WL 13

PT
Relax SH n/a 18

111
Care SOL ≥ 30m/ WASO ≥ 60m/ TST ≤ 6.5 hr, ≥ 3 n/w, ≥ 6 mo + daytime Ilness 55+ CBTI Group 8 46 Plac 46

RI
Rybarczyk 2005

imp

SC
112
Savard 2005 Comm SOL or WASO > 30m, SE < 85%, ≥ 3 n/w, ≥ 6 mo + daytime imp Cancer 18+ CBTI Group 8 27 WL 30

113
Savard 2014 Care ISI ≥ 8 or ≥ 2 nights of sleepmedication in last 2 weeks Cancer 18-75 CBTI Indiv 6 81 No tx 81

U
CBTI SH n/a 80

AN
114
Sivertsen 2006 Comm Poor sleep ≥ 3 mo + daytime imp Allowed 55+ CBTI Indiv 6 18 Plac 12

115

M
Smith 2015 Care SOL or WASO > 30m, ≥ 2 n/w, > 1 mo Knee - CBTI Indiv 8 50 Plac 50

osteoarthritis

D
116
Soeffing 2008 Comm SOL or WASO > 30m, ≥ 3 n/w, ≥ 6 mo + daytime imp Excluded 50+ CBTI Indiv 8 20 Plac 27

Stanton 1989
117
Comm Average SOL > 30m, ≥ 6 mo
TE Allowed - Relax Indiv 4 15 Plac 15

SC Indiv 4 15
EP

118
Steinmark 1974 Univ Average SOL > 30m, ≥ 6 mo Allowed - RelaxA Group 4 12 WL 12

RelaxB Group 4 12
C

119
Strom 2004 Comm SOL / WASO/ early awakening > 30m, ≥ 3 n/w, ≥ 3 mo + daytime Excluded 18+ CBTI SH n/a 54 WL 55
AC

imp

120
Swift 2012 Comm no in- or exclusion criteria Allowed 18+ CBTI Group 1day 75 WL 76

121
Talbot 2014 Comm ISI > 14 + difficulty initiating or maintaining sleep + daytime imp PTSD 18-65 CBTI Indiv 8 29 WL 16

treatment

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 ACCEPTED MANUSCRIPT

Recruit Co- F2F N Contr N

study ment Definition insomnia morbidity Age interv format sess EXP group CTR

122
Taylor 2010 Care Average SE < 85% , ≥ 6 mo + regular use of sleep medication Excluded 18+ SR Indiv 8 24 WL 22

PT
123
Taylor 2014 Univ SOL or WASO > 30m, ≥ 3 n/w, ≥ 3 mo + daytime imp Allowed 18-27 CBTI Indiv 6 17 WL 17

RI
124
Turner 1979 Comm Not reported Allowed - Relax Indiv 4 10 No tx 10

Pdox Indiv 4 10

SC
PR Indiv 4 10

125
Van Straten 2009 Comm SOL / WASO / early awakening > 30m, ≥ 3 n/w, ≥ 1 mo Allowed 18+ CBTI SH n/a 126 WL 121

U
126

AN
Van Straten 2013 Comm SOL > 30m, ≥ 3 n/w, ≥ 3 mo Allowed 18+ CBTI SH n/a 59 WL 59

127
Vincent 2009 Comm SOL or WASO > 30m, ≥ 4 n/w, ≥ 6 mo + daytime imp Allowed 18+ CBTI SH n/a 59 WL 59

M
128
Waters 2003 Comm SOL and (WASO > 30 mins or NWAK > 3) for ≥ 4 nights week for ≥ Excluded 18-59 Relax Indiv 4 13 Info 16

1 month SC+SR Indiv 4 14

D
129
Woolfolk 1983 Comm Average SOL ≥ 50m, ≥ 6 mo TE Excluded 18+ RelaxA Group 4 8 WL 7

RelaxB Group 4 10

RelaxC Group 4 9
EP

130
Wu 2006 Comm SOL or WASO ≥ 30m, ≥ 6 mo + daytime imp Excluded - CBTI Group 16 19 Plac 19
C

131
Zwart 1979 Univ Average SOL ≥ 30m Allowed - SC Group 4 9 WL 8
AC

Abbreviations: AASM = American Academy of Sleep Medicine; AT = autogenic training; CD = cognitive distraction; Comm = Community; CMI =
comorbid insomnia; CT = cognitive therapy; DSISD = Duke Structured Interview for Sleep Disorders; F2F = face-to-face; ICSD = International
Classification of Sleep Disorders; ISI = insomnia severity index; NEXP = number of patients in experimental condition; Nctrl = number of patient in
control condition; NWAK = number of awakenings; NR = not reported; PE = psycho-education; PI = primary insomnia; PR = progressive
relaxation; PSQI = Pittsburgh Sleep Quality Index; RDC = Research Diagnostic Criteria; SC = stimulus control; SE = sleep efficiency; SH =
sleephygiene; SIS-D = Structured Interview for Sleep Disorders for DSM-III-R ; SR = sleep restriction; TST = total sleep time; WL = waitlist;

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Table 2. Main post-test effects of insomnia treatments

Outcome Nc Hedges g (95% CI) I2 (95% CI) NNT

38 0.98 (0.82-1.15) 74 (63~80) 1.95
Insomnia severity index

PT
31 0.92 (0.79-1.06) 51 (19~67) 2.07
Without 7 outliers1
Sleep efficiency (SE) 79 0.71 (0.61-0.82) 70 (61~75) 2.60

RI
Without 14 outliers2 65 0.68 (0.60-0.74) 34 (5~51) 2.70
Pittsburgh sleep quality index3 19 0.65 (0.51-0.79) 39 (0~64) 2.82

SC
Wake after sleep onset (WASO) 71 0.63 (0.53-0.73) 60 (46~68) 2.91
Without 9 outliers4 62 0.66 (0.57-0.74) 40 (14~55) 2.78

U
Sleep onset latency (SOL) 108 0.57 (0.50-0.65) 48 (33~58) 3.18
Without 9 outliers5 99 0.55 (0.48-0.61) 27 (3~43) 3.31

AN
Sleep quality (SQ) 40 0.40 (0.24-0.56) 74 (64~80) 4.50
Without 6 outliers6 34 0.45 (0.31-0.59) 49 (17~65) 4.00

M
Number of awakenings (NWAK) 36 0.28 (0.16-0.40) 29 (0~52) 6.41
Without 2 outliers7 34 0.28 (0.17-0.38) 11 (0~42) 6.41

D
Total sleep time (TST) 91 0.16 (0.08-0.24) 47 (30~58) 11.11

1
Without 9 outliers8
2
82
3
TE
0.17 (0.11-0.24)
4
14 (0~35)
5
10.42
6 7
3 lower and 4 higher; 7 lower and 7 higher; no outliers present; 6 lower and 3 higher; 3 lower and 6 higher; 4 lower and 2 higher; 1 lower and 1
8
higher; 6 lower and 3 higher; * p < 0.05; ** p < 0.01; 95% CI = 95% confidence interval; Nc = number of comparisons; NNT = number needed to treat
C EP
AC

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Table 3. Post-test effects of insomnia treatment on SOL, SE and ISI: subgroup analyses

Sleep Onset Latency (SOL) Sleep Efficiency (SE) Insomnia Severity Index (ISI)
2 2 2
NC g (95% CI) I (95% CI p NC g (95% CI) I (95% CI p NC g (95% CI) I (95% CI p
TREATMENT VARIABLES

PT
Full CBTI
Yes 44 0.47 (0.41 – 0.53) 51 (27~65) 0.25 47 0.63 (0.56-0.69) 70 (58~77) 0.41 34 0.82 (0.74-0.91) 75 (65~81) 0.98
No 64 0.61 (0.52 - 0.70) 44 (20~58) 32 0.69 (0.58-0.79) 70 (55~78) 4 1.03 (0.79-1.26) 48 (0~81)

RI
Type of treatment
CBTI 44 0.47 (0.41 – 0.53) 51 (27~65) 0.03 47 0.63 (0.56-0.69) 70 (58~77) < 0.01 34 0.82 (0.74-0.91) 75 (65~81) 0.67
5)
Behavioral 12 0.38 (0.20 - 0.55) 45 (0~70) 13 0.68 (0.50-0.85) 67 (32~80) 2 0.90 (0.53—1.26) 80 n/a

SC
Relaxation 22 0.63 (0.46 – 0.80) 35 (0~60) 5 0.18 (-0.09-0.45) 0.0 (0~64) - - - -
5)
Other 30 0.72 (0.59 – 0.84) 42 (0~62) 14 0.87 (0.71 - 1.03) 72 (47~82) 2 1.12 (0.81-1.42) 0 n/a
Treatment format

U
F2F individual 50 0.61 (0.51 – 0.71) 50 (27~63) 0.07 37 0.66 (0.56-0.77) 47 (17~64) 0.03 14 1.11 (0.94-1.28) 68 (37~80) 0.21
F2F group 33 0.59 (0.49 – 0.68) 42 (3~61) 17 0.90 (0.78-1.01) 79 (65~85) 9 0.98 (0.82-1.13) 48 (0~74)

AN
Selfhelp 25 0.42 (0.34 – 0.49) 42 (0~63) 25 0.52 (0.44-0.59) 71 (54~80) 15 0.68 (0.58-0.79) 78 (62~85)
1
Number of sessions
1-4 41 0.49 (0.38-0.60) 44 (13~61) 0.06 16 0.54 (0.39-0.69) 12 (0~52) 0.01 4 1.03 (0.79-1.27) 40 (0~79) 0.44
5-6 26 0.66 (0.56-0.76) 49 (11~67) 22 0.84 (0.73-0.95) 76 (63~83) 10 1.12 (0.96-1.29) 52 (0~75)

M
7 or more 16 0.68 (0.52-0.84) 43 (0~67) 16 0.88 (0.72-1.04) 57 (13~74) 9 0.89 (0.68-1.10) 74 (40~85)
n/a (selfhelp) 25 0.42 (0.34 – 0.49) 42 (0~63) 25 0.52 (0.44-0.59) 71 (54~80) 15 0.68 (0.58-0.79) 78 (62~85)

D
PATIENT VARIABLES
Population
Community
Other
79
29
0.47 (0.41 – 0.53)
0.64 (0.54 – 0.74)
51 (34~62)
29 (0~54)
TE
0.10 59
20
0.60 (0.54-0.66)
0.77 (0.66-0.88)
70 (61~77)
64 (37~77)
0.10 26
12
0.82 (0.73-0.91)
0.93 (0.78-1.08)
78 (68~84) 0.59
54 (0~74)
Comorbidity
Yes 20 0.63 (0.52 – 0.75) 36 (0~62) 0.38 20 0.87 (0.75-0.99) 55 (16~72) 0.03 14 0.90 (0.76-1.05) 68 (37~80) 0.65
EP

No 88 0.49 (0.43 – 0.55) 49 (33~60) 59 0.58 (0.52-0.64) 70 (61~77) 24 0.82 (0.73-0.91) 77 (65~83)
Sleep medication
Allowed 51 0.46 (0.40 – 0.52) 49 (25~63) < 0.01 41 0.58 (0.52-0.65) 70 (57~77) 0.22 25 0.77 (0.68-0.86) 76 (64~83) 0.13
C

Not allowed 47 0.59 (0.49 – 0.68) 48 (22~62) 35 0.76 (0.66-0.87) 69 (55~77) 11 1.06 (0.89-1.22) 62 (10~79)
5)
Not reported 10 0.93 (0.69 - 1.17) 0 (0~53) 3 0.99 (0.65-1.32) 0 (0~73) 2 1.58 (0.91-2.25) 0 n/a
AC

3
Age
Younger adults only 21 0.70 (0.57 – 0.84) 0 (0~41) 0.02 13 0.99 (0.84-1.15) 0 (0~49) < 0.01 10 1.02 (0.84-1.19) 72 (38~84) 0.16
All adults 36 0.42 (0.35 – 0.49) 52 (24~66) 29 0.55 (0.49-0.63) 71 (56~79) 19 0.73 (0.63-0.84) 78 (65~85)
Older adults only 24 0.52 (0.40 – 0.64) 48 (7~67) 27 0.82 (0.71-0.94) 72 (58~80) 6 1.11 (0.92-1.31) 0 (0~61)
Not reported 27 0.63 (0.51 – 0.75) 52 (17~68) 10 0.34 (0.18-0.50) 0 (0~53) 3 0.68 (0.41-0.95) 35 (0~81)

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STUDY VARIABLES
Year of publication
16 1.03 (0.80 – 1.27) 0 (0~45) < 0.01 - - - - < 0.01 - - - - 0.82
1970-1979
16 0.73 (0.53 - 0.92) 52 (0~72) - - - - - - - -
1980-1989 5)
6 0.35 (0.07 – 0.64) 0 (0~61) 7 0.56 (0.30-0.83) 55 (0~79) 2 1.15 (0.66-1.64) 0 n/a
1990-1999

PT
37 0.41 (0.32 - 0.49) 9 (0~39) 38 0.46 (0.38-0.55) 58 (37~70) 8 0.71 (0.54-0.89) 82 (62~89)
2000-2009
33 0.53 (0.46 – 0.60) 64 (46~75) 34 0.77 (0.70-0.85) 74 (62~80) 28 0.87 (0.78-0.96) 73 (58~80)
2010+
Type of control

RI
No treatment 21 0.66 (0.54 – 0.77) 53 (13~70) 0.09 9 0.57 (0.44-0.70) 77 (50~86) 0.27 3 0.63 (0.45-0.81) 88 (50~94) 0.03
Waitlist 54 0.49 (0.43 – 0.56) 53 (33~65) 43 0.68 (0.61-0.75) 76 (68~82) 25 0.95 (0.85-1.04) 76 (64~83)
Placebo 20 0.47 (0.34 – 0.61) 50 (5~69) 15 0.60 (0.45-0.74) 51 (0~72) 8 0.79 (0.60-0.97) 32 (0~69)

SC
5)
Info/other 13 0.45 (0.28 – 0.62) 0 (0~49) 12 0.59 (0.42-0.77) 0.0 (0~50) 2 0.41 (-0.07-0.90) 0 n/a
Allocation sequence
adequate 43 0.49 (0.43-0.55) 62 (44~72) 0.51 46 0.67 (0.60-0.73) 76 (67~81) 0.13 27 0.86 (0.77-0.94) 78 (68~84) 0.53

U
not reported 65 0.57 (0.48-0.65) 33 (4~50) 33 0.56 (0.44-0.67) 53 (25~68) 11 0.79 (0.60-0.98) 56 (0~76)
Allocation concealed

AN
Yes 26 0.39 (0.32-0.47) 53 (2-~69) < 0.01 26 0.58 (0.50-0.65) 73 (58~81) 0.54 14 0.67 (0.56-0.78) 74 (52~84) 0.08
Not reported 82 0.63 (0.56-0.70) 38 (16~53) 53 0.71 (0.63-0.79) 67 (55~75) 24 1.03 (0.92-1.15) 67 (46~77)
Study drop-out
5)
Unknown 11 0.71 (0.46-0.97) 61 (7~78) 0.62 2 0.13 (-0.44-0.69) 0 n/a 0.21 - - - - 0.25

M
0-9% 34 0.58 (0.47-0.70) 14 (0~44) 28 0.66 (0.54-0.78) 10 (0~44) 13 0.90 (0.73-1.08) 65 (26~79)
10-19% 47 0.50 (0.43-0.57) 57 (37~68) 32 0.68 (0.61-0.76) 80 (73~85) 17 0.95 (0.94-1.05) 77 (62~85)
20% or more 16 0.46 (0.34-0.57) 52 (0~71) 17 0.55 (0.44-0.66) 73 (54~82) 8 0.61 (0.46-0.75) 68 (13~83)

D
ITT analyses
Yes 51 0.51 (0.44-0.57) 62 (47~71) 0.67 50 0.66 (0.60-0.73) 75 (67~80) 0.09 33 0.83 (0.75-0.91) 74 (63~81) 0.67
No / not reported 57 0.54 (0.45-0.63) 25 (0~46)
TE 29 0.55 (0.43-0.67) 50 (16~67) 5 1.08 (0.77-1.40) 73 (0~87)
PUBLIATION BIAS
Adjustment for Add 27 Egger’s regression Add 21 Egger’s regression Add 13 Egger’s regression
EP
4
publication bias 0.41 (0.33 – 0.50) intercept p < 0.01 0.49 (0.37-0.61) intercept p = 0.01 0.71 (0.54-0.89) intercept p < 0.01
1 2 3
selfhelp treatments excluded; studies not reporting this were excluded (WASO, n=2; SQ, n=2); studies not reporting inclusion range for age were excluded (WASO, n=6; SQ,
4 5
n=3); trim and fill procedure which estimates the number of missing studies (number that needs to be added) and produces the effect size after adding those studies; the 95%
C

2
CI of I cannot be calculated when the number of groups is lower than three; * p < 0.05, ** p < 0.01; F2F = face-to-face
AC

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Table 4. Association between post-test treatment effects (SOL, SE and ISI) and treatment-, patient- and study variables (standardized regression
coefficients of multivariate metaregression analyses)

Sleep Onset Latency (SOL) Sleep Efficiency (SE) Insomnia Severity Index (ISI)

PT
g (95% CI) P g (95% CI) P g (95% CI) p
TREATMENT VARIABLES
Full CBTI
Yes Ref 0.56 n/a n/a

RI
No 0.08 (-0.18 -0.33)
Treatment format
F2F individual Ref 0.62 Ref 0.03 Ref 0.05

SC
F2F group -0.04 (-0.23-0.16) 0.33 (0.04-0.62) -0.47 (-1.01-0.08)
Selfhelp -0.13 (-0.38-0.13) -0.05 (-0.36-0.26) -0.56 (-1.01- -0.11)
PATIENT VARIABLES

U
Population
Community Ref 0.55 Ref 0.28 n/a

AN
Other 0.06 (-0.14-0.26) 0.16 (-0.13-0.45)
Comorbidity
Yes n/a Ref 0.78 n/a
No -0.05 (-0.36-0.27)

M
Sleep medication
Allowed Ref 0.28 Ref 0.65 Ref 0.34
Not allowed 0.02 (-0.18-0.23) 0.13 (-0.15-0.41) -0.37 (-0.87-0.14)

D
Not reported 0.28 (-0.07-0.63) 0.06 (-0.56-0.69) -0.01 (-0.94-0.92)
Age TE
Younger adults only Ref 0.42 Ref 0.01 Ref 0.02
All adults -0.17 (-0.41-0.08) -0.28 (-0.62-0.06) -0.61 (-1.07- -0.14)
Older adults only -0.20 (-0.46-0.06) -0.22 (-0.58-0.14) -0.28 (-1.00-0.43)
EP
Not reported -0.14 (-0.38-0.11) -0.70 (-1.13- -0.27) -0.81 (-1.43- -0.19)
STUDY VARIABLES
Year of publication -0.001 (-0.012-0.009) 0.85 0.02 (-0.001-0.05) 0.06 n/a
Type of control
C

No treatment Ref 0.16 n/a Ref < 0.01

Waitlist -0.10 (-0.34-0.14) 0.60 (0.03-1.17)
AC

Placebo -0.27 (-0.55-0.01) 0.33 (-0.33-0.99)

Info/other -0.29 (-0.62-0.05) -0.99 (-1.91- -0.08)
Allocation sequence
Adequate n/a Ref 0.48 n/a
Not reported 0.11 (-0.19-0.42)

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Allocation concealed
Yes Ref < 0.01 n/a Ref 0.02
Not reported 0.27 (0.08-0.46) 0.45 (0.09-0.81)
Study drop-out
0-9% n/a Ref 0.80 Ref 0.35

PT
10-19% 0.09 (-0.16-0.35) 0.22 (-0.15-0.59)
20% or more 0.13 (-0.17-0.42) 0.20 (-0.23-0.63)
unknown -0.11 (-0.90-0.67) -

RI
ITT analysis n/a
Yes Ref 0.61 n/a
No/not reported -0.07 (-0.33-0.19)

SC
R squared 0.30 0.32
95% CI = 95% confidence interval; CBTI = cognitive behavioral treatment; F2F = face-to-face; g = hedges g; ITT = intention to treat

U
AN
M
D
TE
C EP
AC

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Figure 1. Flow-chart of studies included in the meta-analysis on psychological treatment for

insomnia (inception to 10 january 2016)


Records identified through database
searching
(n = 2.017)

PT

RI
Removing duplicates

(n = 290)

SC


Records screened (n = 1.727) Records excluded (n = 1.503 )

U




AN
Full-text articles assessed for
eligibility (n = 224)
Full-text articles excluded (n = 137 )
• No RCT (n=21)
• No CBTI components in therapy (n=23)
• No waitlist/care-as-usual comparison (n=28)
M

• Secondary analysis (n=20)

• Tapering medication (n=5)
Studies included in meta-analysis • Other (n=40)

D

(n = 87)


TE

EP

C
AC